Cleared Traditional

K934981 - DENTAL DRILL

K934981 is an FDA 510(k) clearance for DENTAL DRILL, manufactured by Eare Consulting Service. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K934981 · Eare Consulting Service · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
107d
Days
Class 1
Risk

K934981 is an FDA 510(k) clearance for the DENTAL DRILL. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Eare Consulting Service (Eilat, IL). The FDA issued a Cleared decision on February 3, 1994 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K934981

510(k) Number K934981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1993
Decision Date February 03, 1994
Days to Decision 107 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 128d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZP Instrument, Diamond, Dental

All 14
Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K934981.
BLUWHITE DIAMOND DENTAL BURS MODIFIED
K120037 · Beavers Dental, Div. Sybron Canada, Ltd. · Apr 2012
SOPHOS DENTAL DIAMOND
K943841 · Sophos Technologic · Sep 1994
DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS
K940908 · Dunhall Pharmaceuticals, Inc. · Aug 1994
DENTAL DIAMOND DRILLS
K923757 · Alpha Industrializacao DE Metais Ltda. · Mar 1993
MANI DIA-BURS
K913651 · The Lahr Consulting Group, Inc. · Jan 1992
DENDIA WERK BURS AND CUTTING DISCS
K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
K934981 · DENTAL DRILL
Download PDF FDA Summary Eare Consulting Servi…